UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049690 |
|---|---|
| Receipt number | R000056596 |
| Scientific Title | Clinical Study on the Therapeutic Effects of Anti-Vascular Endothelial Growth Factor Therapy and Combined Steroid Therapy in Macular Edema Associated with Retinal Vein Occlusion in Relation to Cytokines |
| Date of disclosure of the study information | 2023/02/21 |
| Last modified on | 2023/12/13 09:15:22 |
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Basic information
Public title
Clinical Study on the Therapeutic Effects of Anti-Vascular Endothelial Growth Factor Therapy and Combined Steroid Therapy in Macular Edema Associated with Retinal Vein Occlusion in Relation to Cytokines
Acronym
Therapeutic Effects of Anti-VEGF Therapy Versus Steroid Combination in RVO
Scientific Title
Clinical Study on the Therapeutic Effects of Anti-Vascular Endothelial Growth Factor Therapy and Combined Steroid Therapy in Macular Edema Associated with Retinal Vein Occlusion in Relation to Cytokines
Scientific Title:Acronym
Therapeutic Effects of Anti-VEGF Therapy Versus Steroid Combination in RVO
Region
| Japan |
Condition
Condition
Patients with macular edema associated with retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between treatment efficacy and ocular cytokine kinetics in macular edema associated with RVO
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anti-VEGF treatment efficacy and cytokine levels
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with macular edema associated with retinal vein occlusion
(2) Patients with visual acuity of 0.8 or less and central retinal thickness of 300um or more
(3) Patients scheduled to receive anti-VGEF medication and expected to continue for at least 12 months
(4) Patients who have not been treated with laser, surgery, or injections at other hospitals
(5) Patients who have been informed of the purpose and content of this study and have given their free and voluntary consent
(6) Patients who are able to visit the hospital and undergo examinations during the observation period
Key exclusion criteria
(1) Patients undergoing other ocular surgery or intravitreal injection of various drugs
(2) Patients with the following diseases
Patients with active uveitis
Patients with iris neovascularization
Patients with poorly controlled glaucoma
Progressive diabetic retinopathy
(3) Other patients deemed inappropriate for inclusion in the study by the investigator
(4) Patients who refuse to cooperate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Noma |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Ophthalmology
Zip code
193-0998
Address
1163 Tate-machi, Hachioji, Tokyo
TEL
+81426655611
nomahide1122@gmail.com
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Noma |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Ophthalmology
Zip code
193-0998
Address
1163 Tate-machi, Hachioji, Tokyo
TEL
+81426655611
Homepage URL
nomahide1122@gmail.com
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board in Tokyo Medical University
Address
6-7-1 Nishi-Shinjuku, Shinjuku, Tokyo
Tel
0333426111
tokyo-med@esct.bvits.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Treatment naive macular edema in RVO
To study the eyes in which anti-VEGF drug therapy or steroid combination therapy was administered.
Collection of visual acuity, retinal thickness, flare values, blood flow, retinal sensitivity and vascular density
Collection of the duration and frequency of anti-VEGF therapy, and whether and how often steroids are used
Management information
Registered date
| 2022 | Year | 12 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056596
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| Registered date | File name |
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